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临床试验/NCT03482310
NCT03482310
已完成
不适用

Restoring High Dimensional Hand Function to Persons With Chronic High Tetraplegia

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 1 人2018年6月1日

概览

阶段
不适用
干预措施
Using the Neuroport cortical recording array to determine the desired grasp pattern for a functional electrical stimulation (FES) system
疾病 / 适应症
Spinal Cord Injuries
发起方
VA Office of Research and Development
入组人数
1
试验地点
1
主要终点
Ability to Form Appropriate Grasp Patterns
状态
已完成
最后更新
2个月前

概览

简要总结

This study is for people who have a paralyzed arm and hand from a spinal cord injury, who have also received a recording electrode array in the brain as part of the BrainGate study. The study will look at the ability of these participants to control different grasping patterns of the hand, both in virtual reality and in his/her actual hand. Movement of the participant's hand is controlled by a functional electrical stimulation (FES) system, which involves small electrodes implanted in the arm, shoulder and hand that use small electrical currents to activate the appropriate muscles.

详细描述

This work aims to advance Brain-Computer-Interfaces (BCls) to provide severely paralyzed persons a natural way of controlling Functional Electrical Stimulation (FES) neuroprostheses for restoring arm and dexterous hand movements. The prospect of using BCI technology for restoring arm and hand movements for reaching and grasping is based on the hypothesis that in a paralyzed human, there is a repeatable and understandable relationship between recordable brain activity and specific aspects of imagined arm movements. Many previous studies have attempted to understand the relationships between brain activity and arm and hand movements in able-bodied monkeys. Little is known about these same relationships in humans, and specifically within the context of trying to control an FES arm and complex hand system. This study will recruit persons who already have BCI and FES systems implanted to take advantage of the possibility of recording high resolution brain activity in human participants. Thus, from this study, we aim to gain a better understanding of how brain signals are related to specific aspects of arm and complex hand movements in humans with paralysis. Additionally, this study will test novel implementations of complex hand movement restoration in Veterans and other persons with chronic hand and arm paralysis.

注册库
clinicaltrials.gov
开始日期
2018年6月1日
结束日期
2023年9月30日
最后更新
2个月前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Cognitively intact (able to follow instructions)
  • A spinal cord injury resulting in at least partial arm paralysis
  • Participant in BrainGate2 clinical trial, having already received an intracortical array and demonstrated the ability to use the neural signals to control a cursor on a monitor.

排除标准

  • Profound visual impairments
  • Participant in BrainGate2 clinical trial with insufficient recordable neural signals (such that the researchers cannot decode a movement intention command signal)

研究组 & 干预措施

Cortical Control of Grasp Patterns

Participants will be asked to think about holding different shaped objects, and the recorded cortical signal patterns will be decoded to match those grasp shapes

干预措施: Using the Neuroport cortical recording array to determine the desired grasp pattern for a functional electrical stimulation (FES) system

结局指标

主要结局

Ability to Form Appropriate Grasp Patterns

时间窗: Outcomes were assessed on average every 3 months for the full time (4 years) that the participant was enrolled in the study.

The success rate for achieving a series of specified grasp patterns will be calculated. This will be a percentage of the target grasp patterns successfully achieved. The reported outcome is an average of the outcomes (mean +/- standard deviation) over the full assessment period

研究点 (1)

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